Normal PhysiologyNCT04344470
Study of Volition: Behavioral Analysis and Clinical Neurophysiological Analysis
A study testing EMG and EEG in people with Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: 'Free will' can be defined as the belief that people have control over their thoughts and movements. The topic of free will is controversial and is still being debated. Science has only partial answers to questions about free will, so researchers want to learn more about it. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology
- What is being tested?
- EMG and EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to 21 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age between 25-45 years
- Right-handed (tested by the Edinburg handedness inventory).
- Able to give informed consent.
- Able to comply with all study procedures.
- Fluent in English.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Illegal drug use within the past 6 months based on history alone. The intent is to exclude those with drug use that may affect study results.
- Self-reported consumption of >14 alcoholic drinks/week for a man and >7 alcoholic drinks/week for a woman.
- Abnormal findings on neurological examination.
- History of current brain tumor, stroke, head trauma with loss of consciousness, epilepsy, or seizures.
- Current episode of major depression or any major psychiatric illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
'Free will' can be defined as the belief that people have control over their thoughts and movements. The topic of free will is controversial and is still being debated. Science has only partial answers to questions about free will, so researchers want to learn more about it. They want to assess the role of consciousness when intentions are present with behavior. This could help to explain the causal role of consciousness in movement or decisions.
Read more
Objective:
To learn more about free will.
Eligibility:
Healthy, right-handed adults ages 25-45
Design:
Participants will be screened with medical history, physical exam, and neurological exam.
Participants will have 1 study visit. It will last up to 4 hours.
Participants will sit in a comfortable chair in front of a screen. They will perform some or all of the following tasks.
Visual Task. Participants will watch different stimuli on the screen and answer simple questions.
Electroencephalography (EEG). An EEG records the electrical activity of the brain ('brain waves'). For the EEG, small electrodes are put on the scalp with an electrode cap. A gel is placed in the space between the electrodes and the scalp. Participants' brain waves will be recorded, including while they decide whether to move their thumb.
Choice/Reaction Time Task. Participants will watch different stimuli on the screen and react to them by moving their wrist. During this task, they will wear an EEG cap on their head and electrodes on their arms and wrists.
Electromyography. Small electrodes will be attached to participants' skin. Their muscle activity will be recorded while they decide whether to move their wrist and during the movement itself.
Transcranial Magnetic Stimulation (TMS): TMS is a non-invasive brain stimulation that uses magnetic field to stimulate nerve cells in your brain. TMS can increase or decrease brain activity in particular area of your brain. TMS operates completely outside of the body and is generally very well tolerated....
Read the detailed description
Study Description:
The main focus of this protocol will be to try to identify the quale of free will, its electrophysiological correlates, and to determine whether this quale plays a causative role in movement.
Objectives:
Primary Objectives:
We will be doing a series of experiments. In the first experiments, we want to explore the behavioral response of normal subjects when they move after a visual stimulus that can be seen or unseen. We want to study behavior in different conditions with movement triggered by stimuli that are seen and not seen. Furthermore, we want to analyze the EEG related to those stimuli to explore sensory and motor processing.
Endpoints:
Primary Endpoints:
Reaction time and accuracies of the responses to different stimuli in different conditions will be identified as well as the subjects subjective experiences. EEG ERP shapes and microstates patterns will also be investigated.
Study Population:
Up to 50 healthy volunteers of both genders between the ages of 25-45, fluent in English and right-handed.
Participant Duration:
The total study is expected to last 48 months, with each individual expected to participate in a single 4-hour outpatient visit at the NIH Clinical Center, but there can be multiple visits.
- Conditions
- Normal Physiology
- Being tested
- EMG, EEG
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMGDevice
EMG will be recorded from two electrodes placed on both extensor carpi radialis (ECR) muscles
EEGDevice
EEG electrodes will be positioned according to 10-20 International System, with every impedance kept under 5 kOhm. EEG data will be amplified, filtered (DC-100 Hz), digitized at 1000 Hz, and stored on a computer for offline analysis.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Healthy Volunteers Receives: Device: EMG; Device: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiment1: Identification of the best characteristics that allow us to create a backward masking effect of the second stimulus on the first one.
We will develop a methodological approach to create the best backward masking effect. We will ask the subjects what they saw, to prove the effectiveness of the backward masking.
Measured: throughout
Experiment 2: Reaction time and accuracies of the responses to different stimuli (symbols, faces, objects, etc.) in different conditions (with and without masking)
Subjects will move to the first stimulus even if unseen. We want to study subjects behavior in different conditions (simple reaction task, choice reaction task, with and without masking) with different stimuli (symbols, faces, objects, etc.). Furthermore, we want to analyze the EEG (classic ERP, microstates, etc.) related to those stimuli. EEG will be also analyzed to study the nature and strength of the visual pathway for movement and the pathway for visual perception at rest.
Measured: throughout
Experiment 1: Identification of the EEG characteristic or ERP shape related to different stimuli and the brain region origin.
We will create a template of the shape of the ERP and the characteristics of EEG related to different stimuli to be identified in the second sub-study.
Measured: throughout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start22 Dec 2020
- Primary completion26 Jun 2023
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lauren B Reoma, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344470
- Sponsor's protocol ID
- 200077
- Other IDs
- 20-N-0077
- Status last verified
- 21 Mar 2024
- First submitted
- 11 Apr 2020
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: .This will be determined at a later time. It is not yet known if it is feasible to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Volition: Behavioral Analysis and Clinical Neurophysiological Analysis
- ClinicalTrials.gov ID
- NCT04344470
- Acronym / sponsor ID
- 200077
- Conditions
- Normal Physiology
- Keywords
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
'Free will' can be defined as the belief that people have control over their thoughts and movements. The topic of free will is controversial and is still being debated. Science has only partial answers to questions about free will, so researchers want to learn more about it. They want to assess the role of consciousness when intentions are present with behavior. This could help to explain the causal role of consciousness in movement or decisions.
Objective:
To learn more about free will.
Eligibility:
Healthy, right-handed adults ages 25-45
Design:
Participants will be screened with medical history, physical exam, and neurological exam.
Participants will have 1 study visit. It will last up to 4 hours.
Participants will sit in a comfortable chair in front of a screen. They will perform some or all of the following tasks.
Visual Task. Participants will watch different stimuli on the screen and answer simple questions.
Electroencephalography (EEG). An EEG records the electrical activity of the brain ('brain waves'). For the EEG, small electrodes are put on the scalp with an electrode cap. A gel is placed in the space between the electrodes and the scalp. Participants' brain waves will be recorded, including while they decide whether to move their thumb.
Choice/Reaction Time Task. Participants will watch different stimuli on the screen and react to them by moving their wrist. During this task, they will wear an EEG cap on their head and electrodes on their arms and wrists.
Electromyography. Small electrodes will be attached to participants' skin. Their muscle activity will be recorded while they decide whether to move their wrist and during the movement itself.
Transcranial Magnetic Stimulation (TMS): TMS is a non-invasive brain stimulation that uses magnetic field to stimulate nerve cells in your brain. TMS can increase or decrease brain activity in particular area of your brain. TMS operates completely outside of the body and is generally very well tolerated....
Detailed description
Study Description:
The main focus of this protocol will be to try to identify the quale of free will, its electrophysiological correlates, and to determine whether this quale plays a causative role in movement.
Objectives:
Primary Objectives:
We will be doing a series of experiments. In the first experiments, we want to explore the behavioral response of normal subjects when they move after a visual stimulus that can be seen or unseen. We want to study behavior in different conditions with movement triggered by stimuli that are seen and not seen. Furthermore, we want to analyze the EEG related to those stimuli to explore sensory and motor processing.
Endpoints:
Primary Endpoints:
Reaction time and accuracies of the responses to different stimuli in different conditions will be identified as well as the subjects subjective experiences. EEG ERP shapes and microstates patterns will also be investigated.
Study Population:
Up to 50 healthy volunteers of both genders between the ages of 25-45, fluent in English and right-handed.
Participant Duration:
The total study is expected to last 48 months, with each individual expected to participate in a single 4-hour outpatient visit at the NIH Clinical Center, but there can be multiple visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: EMG, Device: EEGHealthy Volunteers |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age between 25-45 years
- Right-handed (tested by the Edinburg handedness inventory).
- Able to give informed consent.
- Able to comply with all study procedures.
Key exclusion criteria (6 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Illegal drug use within the past 6 months based on history alone. The intent is to exclude those with drug use that may affect study results.
- Self-reported consumption of >14 alcoholic drinks/week for a man and >7 alcoholic drinks/week for a woman.
- Abnormal findings on neurological examination.
- History of current brain tumor, stroke, head trauma with loss of consciousness, epilepsy, or seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMGEMG will be recorded from two electrodes placed on both extensor carpi radialis (ECR) muscles | Device | Healthy Volunteers |
| EEGEEG electrodes will be positioned according to 10-20 International System, with every impedance kept under 5 kOhm. EEG data will be amplified, filtered (DC-100 Hz), digitized at 1000 Hz, and stored on a computer for offline analysis. | Device | Healthy Volunteers |
Primary outcome
Experiment1: Identification of the best characteristics that allow us to create a backward masking effect of the second stimulus on the first one.
Time frame: throughout
We will develop a methodological approach to create the best backward masking effect. We will ask the subjects what they saw, to prove the effectiveness of the backward masking.
Experiment 2: Reaction time and accuracies of the responses to different stimuli (symbols, faces, objects, etc.) in different conditions (with and without masking)
Time frame: throughout
Subjects will move to the first stimulus even if unseen. We want to study subjects behavior in different conditions (simple reaction task, choice reaction task, with and without masking) with different stimuli (symbols, faces, objects, etc.). Furthermore, we want to analyze the EEG (classic ERP, microstates, etc.) related to those stimuli. EEG will be also analyzed to study the nature and strength of the visual pathway for movement and the pathway for visual perception at rest.
Experiment 1: Identification of the EEG characteristic or ERP shape related to different stimuli and the brain region origin.
Time frame: throughout
We will create a template of the shape of the ERP and the characteristics of EEG related to different stimuli to be identified in the second sub-study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. .This will be determined at a later time. It is not yet known if it is feasible to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren B Reoma, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG and EEG in people with Normal Physiology, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiment1: Identification of the best characteristics that allow us to create a backward masking effect of the second stimulus on the first one. (time frame: throughout). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.